Treatment of Nodular Basal Cell Carcinoma (BCC) With Imiquimod 5% Cream After Curettage

NCT00314756 | Completed Phase 4

• 1 other identifier: BG04-484
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the efficacy of treating a nodular basal cell carcinoma with imiquimod cream after initial treatment with curettage

Conditions

Basal Cell Carcinoma

Keywords

imiquimod cream; nodular basal cell carcinoma; curettage

Outcome Measures

Primary Outcomes (1)

• histologic clearance of basal cell carcinoma

Interventions

imiquimod DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are willing and able to give informed consent;
• Are at least 18 years of age;
• Are willing to comply with all study requirements, evaluations, and procedures
• Have 1 clinically typical, visible nodular BCC lesion which meets the following criteria:
• a primary lesion (not recurrent, not previously treated or biopsied)
• non-infected
• size between 0.25 and 1.5 cm2
• located at least 1 cm from the eyes, nose, mouth, ear, and hairline to exclude the H-zone of the face
• clinically consistent with nodular BCC
• histologically consistent with nodular BCC and have no histological evidence of a morpheaform or micronodular pattern
• suitable for treatment with surgical excision
• easily identifiable and treatable by subject or reliable subject representative
• Are free of any significant physical abnormalities or previous scarring in the potential application site area that may cause difficulty with examinations.
• Are willing to stop using over-the-counter retinol products or products containing alpha or beta hydroxyacids in the treatment and surrounding area 8 hours prior to treatment with the imiquimod cream and clinic visits.

You may not qualify if:

• Have evidence of clinically significant, unstable, cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease that may interfere with completion of the study.
• Have any dermatological disease in the treatment or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination.
• Have a BCC lesion located within 1 cm of the eyes, nose, mouth, ear, and hairline.
• Are pregnant at the screening or treatment initiation visit.
• Have known allergies to any excipient in the study cream
• Have undergone any surgical procedures in the potential treatment area within 4 weeks of the screening/treatment initiation visit. In addition, skin in the potential application area must be healed.

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Phillip M Williford, MD

  Wake Forest University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2006
• First Posted: April 14, 2006
• Study Start: March 1, 2005
• Study Completion: November 1, 2005
• Last Updated: August 22, 2023

Record last verified: 2005-03

Locations

US (1)